Overuse of antipsychotic meds risks lives of the elderly

Orange County Register (CA)

06-18-13

June 16--Grandma didn't smile anymore.

After four months at Carriage House Nursing Center and Windsor Gardens of
Fullerton, 94-year-old Joanna Sienkiewicz had gone from spry and bossy to barely
there. Medical records indicate attendants were giving her 15 milligrams a day
of the powerful antipsychotic drug, Abilify, noting she was agitated and
resisted care.

"Before she was lively, then she became completely listless," said granddaughter
Anna Woronowicz, 34. "It was awful. We felt powerless."

At Windsor Gardens Convalescent Center of Anaheim, Richard Millikan, 71, was
sedated on antipsychotics although his family never gave their consent, his
ex-wife, Maria, alleged in a lawsuit.

"They kept him thoroughly sedated all the time, they never moved him, they never
gave him any attention," Maria Millikan said.

At Windsor Vallejo Care Center, Robert Sohl, 87, was so doped out on the
antipsychotic Seroquel, his family said in a lawsuit, that he stopped eating and
drinking, eventually dying from dehydration.

"He was completely in la-la land. He didn't know who he was or where he was,"
said his daughter, Michelle Sohl.

The federal Food and Drug Administration warns that antipsychotics should not be
used on elderly people with dementia. Prescribing such drugs to the elderly for
dementia or Alzheimer's can hasten death, according to the FDA. Yet, medical
experts and federal regulators say antipsychotic drugs are being used at an
alarming rate by nursing homes to chemically restrain hard-to-handle seniors.
More than 20 percent of the residents in nursing homes across the country
receive antipsychotic drugs for reasons not approved by regulators, according to
data analyzed by the Orange County Register.

The federal Centers for Medicare and Medicaid Services (known as CMS) began
tracking the use of antipsychotics in nursing homes for quality purposes in
2011, after an Office of Inspector General report showed widespread abuse in
convalescent centers. Despite a campaign by regulators to reduce such dosing,
experts say progress is slow.

"Most of the care in nursing homes is pharmacological," said Dr. Victor
Molinari, professor of aging at the University of South Florida. "Some people
say nursing homes are basically psychiatric institutions without the trained
psychiatric staff. There's this tendency to overuse psychiatric medicine and
underuse other methods."

Molinari continued, "The issue is not heartless nursing home administrators,
it's just they feel they don't have the resources to combat the problem. They
reach for the prescription pad as opposed to having a more thoughtful approach
to what's triggering the erratic behavior."

While nursing home reform advocates say antipsychotics are often used to offset
low staffing, an analysis by the Register of 12,000 homes nationally failed to
find a statistical association between low staffing and abusive drug
prescriptions, meaning that low staffing is not a reliable predictor of over-use
of antipsychotic drugs.

Federal agencies have fined pharmaceutical companies, including Astra Zeneca,
Eli Lilly and AbbVie, for illegally marketing antipsychotics such as Seroquel,
Zyprexa and Depakote, for "off-label" uses. Doctors are often paid to help with
such marketing. Newly mandated federal disclosures show that drug companies have
paid millions of dollars to thousands of doctors for helping to test or promote
many of their drugs.

TRYING 'WARM MILK'

Joanna Sienkiewicz, Richard Millikan and Robert Sohl, the elderly patients whose
deaths prompted lawsuits, were all in nursing facilities operated by Los
Angeles-based S&F Management, which used the brand name "Windsor."

An analysis by the Orange County Register of 2011-12 data provided by the CMS
found that Windsor residents received dangerous antipsychotic drugs at a rate
higher than any of the largest chains in California, defined as those with more
than 3,000 beds. Twenty-six percent of Windsor residents without schizophrenia
received antipsychotics, compared to a statewide median of 17 percent.
Nationally, the median is 22 percent.

Officials at the 3,865-bed Windsor chain insisted that they discourage the use
of antipsychotics to control difficult patients who are not schizophrenic.

"It's frowned upon and discouraged. Can I say it doesn't happen 100 percent of
the time? I probably can't say that," said Dr. Jameel Hourani, Windsor's
corporate medical director. "We prefer to use non-pharmacological methods to
treat patients, initially. If we can't stop (the behavior), we'll try to give
them warm milk."

Hourani suggested that the Windsor chain's numbers are skewed by one home that
specializes in patients with psychological problems, Windsor Palms Care Center
of Artesia. CMS data shows that 60 percent of patients there are on
antipsychotics, one of the highest rates for antipsychotic use in the nation.

"No other nursing homes will take these (mental health) patients," Hourani said.

Disclosures by drug companies show that Hourani and a drug research company he
worked for were paid nearly $1 million to conduct research on behalf of
companies that produce antipsychotics and other drugs in 2011 and 2012. Hourani
said that his former employer, California Clinical Trials, received the bulk of
the $977,257 that drug companies paid for that research.

Hourani, who graduated from the West Virginia School of Osteopathic Medicine,
was the principal investigator on research funded by Pfizer, maker of the
antipsychotic drug Zeldox, and Merck, maker of Saphris, according to those
companies' disclosures. Hourani was also paid $38,513 directly in 2012 by Forest
Pharmaceuticals, maker of the antipsychotic Cariprazine, for speaking, meals and
travel.

Although Hourani is the head physician for the Windsor homes, he said he only
prescribes drugs for the Windsor home in Los Angeles and that it is Windsor
psychiatrists who prescribe the antipsychotics. CMS data shows that home,
Windsor Care Cheviot Hills, prescribes antipsychotics to 16 percent of its
patients, below the state median.

Sienkiewicz entered Carriage House in September 2005, which became Windsor
Gardens during her four-month stay.

Records show that Sienkiewicz, who suffered from dementia, was given an
antipsychotic drug called Abilify for "psychosis manifested by agitation and
resisting care." Her family alleged in a lawsuit that Carriage House Nursing
Center and Windsor Gardens of Fullerton did not get the required consent to give
the drug. The family believes the drug was used mainly to restrain her from
acting out.

"She was out of it. Not coherent. Not interacting with us," said Anna
Woronowicz, the granddaughter. "She didn't seem happy to be with us."

Abilify and other antipsychotics are not federally approved for the treatment of
Alzheimer's or dementia. In fact, the Food and Drug Administration offers its
strongest warning, known as a "black box warning," that such use can increase
the likelihood of death. There's an increased risk of stroke, heart attack and
falls. But there are no laws prohibiting doctors from prescribing the medication
for an "off-label" use -- that is, for medical conditions for which a drug has
not been approved.

Costa Mesa psychiatrist Jason Kellogg, who specializes in geriatrics, approved
the Abilify for Sienkiewicz, according to medical records. Kellogg in 2010
prescribed antipsychotics to 66 percent of his patients in a Medicare subsidy
program called Part D, compared to the national average of 49 percent, according
to a database compiled by the ProPublica online newsroom.

Kellogg did not respond to requests for an interview, which were left with a
secretary.

Sienkiewicz died in January of 2006 after being moved to a hospital because her
blood had become infected, according to her family.

Sienkiewicz's daughter, Marie Woronowicz, sued Windsor and Kellog for wrongful
death, lack of informed consent and medical malpractice. The case was settled
out of court, according to legal records, and the settlement remains
confidential.

Richard Millikan's ex-wife said in a 2008 lawsuit that informed consent was not
obtained from his family before he was given antipsychotic drugs at Windsor
Gardens Convalescent Center of Anaheim. Millikan suffered from dementia and died
in June 2008 from pulmonary congestion. His death certificate also says he
suffered from leg ulcers. Maria Millikan said she was forced to drop her suit
because she didn't have any legal standing as a former spouse.

Federal numbers show that Windsor Gardens of Anaheim administers antipsychotics
to 43 percent of its patients who do not have a diagnosis of schizophrenia.
That's nearly triple the state rate.

Carole Lillis, vice president of clinical services for Windsor, said she could
not comment on individual cases. But Lillis said the CMS data doesn't account
for some psychosis-causing ailments, such as manic depression. Lillis added the
company has been striving to meet a 15 percent reduction in the use of
antipsychotics, a goal set nationally by the CMS.

About 17 percent of the residents at Windsor Gardens in Fullerton, where
Sienkiewicz stayed, typically receive antipsychotic drugs without a diagnosis of
schizophrenia, according to the 2011-2012 data.

That rate is equivalent to the median for all California nursing homes.

FEDERAL REGULATORS 'SENDING A MESSAGE'

The California Advocates for Nursing Home Reform warn against leaving loved ones
at homes with a high rate of antipsychotic drug use.

"Unless you have a severe mental illness and have a legitimate need for these
drugs, it is not safe to enter a nursing home that uses antipsychotic drugs at a
high rate," says the group's website.

Data collected by the federal CMS shows that an average of 22 percent of the
people in nursing homes nationally were receiving antipsychotics in December
2012, down from 23 percent in June 2011. That's far below the 15 percent
reduction sought by CMS but trending in the right direction, according to CMS
officials.

Besides Windsor, the 3,765-bed Longwood Management chain -- which operates Park
Anaheim Health Care -- is at 21 percent, well above the state median. The other
large California chains -- Plum, Country Villa, The Ensign Group, Skilled
Healthcare, Sava Senior Care and Covenant -- are at or below the state's 17
percent median.

Hoping to curb the use of antipsychotics in nursing homes, CMS officials search
for such things as excessive dosing or prolonged use, issuing fines that can
reach into the thousands per day.

"We are sending a loud and clear message from CMS that there will be enforcement
for any misuse," said Alice Bonner, who oversaw nursing homes for the CMS until
she was promoted to another position this year.

Surveyors in each state -- who annually visit each nursing home -- are being
trained by the CMS to watch for antipsychotics abuse.

A 2011 investigation by the Office of Inspector General for the Department of
Health and Human Services found that 83 percent of antipsychotic drug claims in
nursing homes were for uses not approved by the FDA. Moreover, $116 million in
claims did not fit Medicare reimbursement criteria.

Omnicare, Inc., a large pharmacy which serves Windsor and other chains, agreed
in 2009 to pay $98 million to settle federal allegations that it received
kickbacks from pharmaceutical manufacturers for recommending their antipsychotic
drugs for use in nursing homes, according to the OIG investigation.

The company issued a prepared statement when asked for comment: "Omnicare, like
other companies in the industry, continues to work closely with CMS and
prescribing physicians to reduce the use of antipsychotic drugs in nursing
homes."

Pharmaceutical companies have also paid heavy fines for suggesting to doctors
that they prescribe antipsychotics for unapproved uses.

In 2007, Bristol-Myers Squibb paid $515 million to settle federal investigations
for, among other things, promoting Abilify for uses not approved by the FDA.

In 2010, AstraZeneca agreed to pay $520 million to settle federal and state
civil accusations it promoted "off label" use of the drug Seroquel to doctors
who treat the elderly and children.

In a statement sent to the Register, AstraZeneca said it tries to comply with
all federal laws and regulations.

"It is and was AstraZeneca's policy to promote our medicines and to conduct
interactions with healthcare professionals in compliance with the laws and
regulations that govern the healthcare community in the United States. We train
AstraZeneca employees to follow our compliance policies," wrote company
spokesman Tony Jewell in an email.

Many in the nursing home industry agree that antipsychotics are being over-used.

"It's the view of our association that the number of residents being prescribed
antipsychotics can be reduced and we continue to explore ways to help our
members prevent and manage difficult behavior without medications," said Deborah
Pacyna, spokeswoman for the California Association of Health Facilities, which
represents about 60 percent of the nursing homes in the state.

Nursing home reformers say the answer is more therapy and fewer chemicals.

"They shouldn't have to rely on the crutch of psychotropic drugs. The answer
isn't a pill," said Anthony Chicotel, attorney for association. "It makes you
less active and less able to communicate your needs."

In California, only six out of 927 nursing homes do not appear to use
antipsychotic drugs, including the Sun Mar Nursing Center in Anaheim.

"We try and avoid the antipsychotic drugs. The spiritual aspect (of treatment)
is very important and we have wonderful family support," said Sarah Lee, social
services director for Sun Mar.

Lee noted all the residents are Korean speakers, as well as all the caregivers.

"We just provide quality of care," said Lee. "Most of the time, it works."

___

(c)2013 The Orange County Register (Santa Ana, Calif.)

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